Philips Ingenia Ambition X MRI Systems Alignment Error in MobiView
Philips is recalling certain Ingenia Ambition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a risk-of-harm hazard (alignment errors affecting image interpretation) where no injuries have been reported to date. The hazard is real rather than theoretical, as it describes a specific functionality defect that could lead to clinical errors, placing it at High severity.
Plain-English summary
Philips North America LLC is recalling Ingenia Ambition X MRI systems (Model Numbers 781356, 782109, and 782138) worldwide. The recall affects approximately 300 units, with 81 units in the US and 219 units outside the US.
The recalled devices have a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This misalignment could affect the accuracy of image interpretation and clinical decision-making based on those images.
Patients and healthcare providers who use affected systems should contact Philips North America LLC for further guidance regarding their specific device. Affected devices can be identified by their model numbers and the serial numbers listed in the recall notice.
The recalled product
- Product
- Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- image-interpretation-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Numbers: (1) 781356
- (2) 782109
- (3) 782138
- UDI-DI: (1) 00884838090040
- (2) 00884838098350
- (3) 00884838108622
- Serial Numbers: (1) 47002
- 47004
- 47011
- 47012
- 47018
- 47019
- 47020
- 47028
- 47029
- 47037
- 47049
- 47052
- 47057
- 47099
Distribution
Distributed nationwide across the United States.
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